The US Supreme Court has ordered a review of the most recent decision in favour of Myriad Genetics’ BRCA1 and BRCA2 gene patents, in the light of a potentially contradictory ruling on a personalised medicine patent.
The latest decision in the long-running legal dispute, which began in 2009, came in 2011 when the Federal Court of Appeals ruled that Myriad’s patents were, after all, valid (see previous news). However, the basis of the recent decision against Prometheus patents for a method to determine optimal drug dose was that natural phenomena cannot be patented (see previous news).
Now the Supreme Court has asked the lower court to review the Myriad case, potentially prolonging this already protracted dispute for more years to come.
Legal experts are divided over how far the two cases are actually related, since the Prometheus patents refer solely to methods of testing whilst the Myriad patents also relate to ‘compositions of matter’. Both cases refer to natural processes or elements; the key is whether the additional steps claimed create sufficient novel transformation to warrant patent protection.
Comment: It seems that no definitive legal resolution in this key US test case on gene patenting is likely anytime soon – but this probably surprises no-one, least of all the biotechnology industry. The main concern is that the uncertainty makes it more difficult to obtain funding for more innovative lines of research and applications.